(91 days)
The ROTOCUT G1 Electromechanical Morcellator in conjunction with the UNIDRIVE GYN Control unit is a motorized unit for morcellating and extracting tissue during laparoscopic procedures in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.
The KSEA ROTOCUT G1 Electronechanical Morcellator in conjunction with the UNIDRIVE GYN control unit is a motorized, reusable surgical device system, intended for the morcellation and extracting tissue during laparoscopic procedures in general surgery, gynecology, and urology by qualified surgeons.
This document is a 510(k) summary for the KSEA ROTOCUT G1 Electromechanical Morcellator. It claims substantial equivalence to predicate devices and does not describe acceptance criteria, performance studies, or clinical trial data. Therefore, I cannot extract the requested information.
Here's why:
- 510(k) Substantial Equivalence: A 510(k) submission generally focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and performance characteristics, often through non-clinical testing (e.g., bench testing, biocompatibility).
- Lack of Clinical Study Details: The provided text is a summary of the 510(k) and the FDA's clearance letter. It does not contain details of specific clinical studies, performance criteria, sample sizes, expert qualifications, or ground truth establishment. The declaration of substantial equivalence usually implies that the performance is considered acceptable based on the predicate device's established safety and effectiveness.
To answer your request, I would need a different type of document, such as a full clinical study report, a regulatory submission with detailed performance data, or an FDA review memorandum that explicitly discusses clinical acceptance criteria and the results of a study designed to meet them.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.